Validation of a Model Estimating the Budget Impact of Video Capsule Endoscopy for Surveillance of Crohn's Disease in an Italian Center.

Background: Crohn's disease is a chronic ailment affecting the gastrointestinal tract. Mucosal healing, a marker of reduced disease activity, is currently assessed in the colonic sections using ileocolonoscopy and magnetic resonance enteroscopy. Video capsule endoscopy (VCE) offers visualization of the entire GI mucosae. Objective: To validate a Crohn's disease model estimating the budget impact of VCE compared with the standard of care (SOC) in Italy. Methods: A patient-level, discrete-event simulation was developed to estimate the budget impact of VCE compared with SOC for Crohn's disease surveillance over 5 years in the Italian setting. Input data were sourced from a physician-initiated study from Sant'Orsola-Malpighi Hospital in Bologna, Italy, and the literature. The care pathway followed hospital clinical practice. Comparators were the current SOC (ileocolonoscopy, with or without magnetic resonance enteroscopy) and VCE. Sensitivity analysis was performed using 500-patient bootstraps. A comparative analysis regarding clinical outcomes (biologics use, surgical interventions, symptom remission) was performed to explore the validity of the model compared with real-world data. Cumulative event incidences were compared annually and semi-annually. Bayesian statistical analysis further validated the model. Results: Implementing VCE yielded an estimated €67 savings per patient per year, with savings in over 55% of patients, compared with SOC. While annual costs are higher up to the second year, VCE becomes cost saving from the third year onward. The real-world validation analysis proved a good agreement between the model and real-world patient records. The highest agreement was found for biologics, where Bayesian analysis estimated an 80.4% probability (95% CI: 72.2%-87.5%) that a decision maker would accept the result as an actual reflection of real-world data. Even where trend data diverged (eg, for surgery [43.1% likelihood of acceptance, 95% CI: 33.7%-52.8%]), the cumulative surgery count over 5 years was within the margin of error of the real-world data. Conclusions: Implementing VCE in the surveillance of patients with Crohn's disease and small bowel involvement may be cost saving in Italy. The congruence between model predictions and real-world patient records supports using this discrete-event simulation to inform healthcare decisions.

Capsule endoscopy in Crohn's disease surveillance: A monocentric, retrospective analysis in Italy.

Background: Crohn's disease (CD) is a potentially debilitating condition that burdens Italian healthcare substantially. The symptomatic management relies on prompt therapy adjustment to reduce flares and follow-up diagnostic inputs to maximise remission. Capsule endoscopy (CE) has introduced advantages in CD diagnostics, allowing the direct inspection of the entire gastrointestinal mucosa. The diagnostic procedure is comparable in effort to standard ileocolonoscopy (IC) but requires no anaesthesia. Whether CE follow-up improves clinical outcomes remains to be defined. Objectives: To provide a preliminary evaluation of CE in terms of clinical outcomes with respect to the standard of care ileocolonoscopy/MRE in Italy. Methods: This retrospective analysis utilises anonymised, monocentric data from the S. Orsola-Malpighi Hospital IBD database in Bologna, Italy, collected between 1999 and 2019. Out of 421 adult patient records, 100 were included in the analysis (50 per arm, matched per demographic and clinical characteristics). The CE represented the intervention arm, whereas ileocolonoscopy/magnetic resonance enterography was the standard of care. The use of biologics, symptomatology course, and surgery were the outcomes. Results: The two techniques performed similarly overall. In general, no significant difference emerged in the use of biologics. The use of biologics appears reduced in the CE group, only in L4 patients after the first follow-up year. Similarly, surgery was seemingly less frequent among L4 patients in the CE group. No difference was found between groups in flare occurrence and duration. CE patients might have experienced longer and earlier first remissions, but no long-term difference persisted. Conclusions: The CE group showed an apparent reduction in biologics and surgery, limiting to L4 diagnoses. More extensive, prospective, multicentre, randomised studies must corroborate these preliminary findings.

Usefulness of panoramic 344°-viewing in Crohn's disease capsule endoscopy: a proof of concept pilot study with the novel PillCam™ Crohn's system.

BACKGROUND: A new capsule endoscopy (CE) system featuring two advanced optics for 344°-viewing and a prolonged operative time has been recently developed for Crohn's disease (CD) patients. Hence, we evaluated, for the first time, the performance of this novel CE and the add-on value of the 344°-viewing in a multi-center real-life setting. METHODS: Consecutive patients with suspected or established CD received the PillCam™ Crohn's System as supplementary diagnostic work-up focused on the small-bowel between June 2017 and June 2018. Technical and clinical data, including the panenteric CE diagnostic yield, the Lewis score and the impact of small-bowel findings on clinical management during a 6-months follow-up (new diagnosis, staging or treatment upgrade) were collected, thereby evaluating the added value of the 344° panoramic-view (lesions detected by camera A and B) over the standard 172°-view (lesions detected by one camera only). RESULTS: Among 41 patients (aged 43 ± 20 years), 73% underwent CE for suspected CD and 27% for established CD. The rate of complete enteroscopy was 90%. No technical failure or retention occurred. Compared to the standard 172° view, the panoramic 344°-view revealed a greater number of patients with a relevant lesion (56.1% vs. 39.0%; P = 0.023), resulting in higher Lewis score (222,8 vs. 185.7; P = 0.031), and improved clinical management (48.8% vs. 31.7%, P = 0.023). CONCLUSIONS: The panoramic 344°-view increases small-bowel CE accuracy, thereby improving the clinical management of CD patients with mild small-bowel active disease. This system should be regarded as a new standard for both small-bowel diagnosis and monitoring in inflammatory bowel diseases.

Proton pump inhibitors: Risks of long-term use.

Proton pump inhibitors are among the most commonly prescribed classes of drugs, and their use is increasing, in particular for long-term treatment, often being over-prescribed and used for inappropriate conditions. In recent years, considerable attention has been directed towards a wide range of adverse effects, and even when a potential underlying biological mechanism is plausible, the clinical evidence of the adverse effect is often weak. Several long-term side effects have been investigated ranging from interaction with other drugs, increased risk of infection, reduced intestinal absorption of vitamins and minerals, and more recently kidney damage and dementia. The most recent literature regarding these adverse effects and their association with long-term proton pump inhibitor treatment is reviewed, and the mechanisms through which these possible complications might develop are discussed.